Chiara Maura Ciniselli


Ciniselli_1 (2)

Chiara Maura Ciniselli


Title of Presentation

“Suitability of mRNA ISH assay for the detection of HPV infection in oropharyngeal squamous cell carcinoma (OSCC) patients: a preliminary evidence”

Date and Place

Session D3

Speaker Biography

Dr. Chiara Maura Ciniselli is currently a researcher at the Fondazione IRCCS Istituto Nazionale dei Tumori (INT) of Milan. She works as biostatistician at the Unit of Medical Statistics, Biometry and Bioinformatics of INT since 2009. Her research areas has been related to the methodological aspects and statistical analysis of data derived from External Quality Assurance schemes (EQA) implemented at both national and international level. Her activity is now principally focused on studies aimed at identifying new non-invasive molecular biomarkers in oncology. She is attending the last year of the PhD course in “Epidemiology, Environment and Public Health” at the University of Milan, focusing on the statistical-methodological aspects related to the identification and validation of new circulating biomarkers.


High risk human papilloma virus (HR-HPV) has been recognized as a causal agent in a subset of head and neck squamous cell carcinomas. The College of American Pathologist recommended routine HPV testing as part of the standard pathological evaluation of resected oropharyngeal squamous cell carcinoma (OSCC) as several researches highlighted a better prognostic pattern for the HPV-positive OSCC patients with respect to HPV-negative ones[1]. An accurate, technically feasibility and cost effective diagnostic test that can be used in a routine setting is thus necessary to appropriately classify OSCC patients according to their HPV status. Several assays are currently available[2], but none offer optimal performance characteristics. Accordingly, different stepwise algorithms have been proposed to optimize the overall reliability of HPV detection. We implemented a pilot study[3] to preliminarily assess the level of interchangeability of the novel mRNA-ISH technique with respect to the standard HPV16 E6/E7 mRNA RT-PCR on 40 cases ad-hoc (target sample) selected from our Institutional biobank, containing more than 700 OSCC patients all tested for HR-HPV infection. The target samples were blindly re-evaluated by mRNA RT-PCR and mRNA-ISH and classified in a qualitative manner as positive or negative. Our results on 37 cases showed a substantial agreement between the two approaches with a Cohen k-statistics value of 0.723 (95% CI, 0.498-0.960). Our experience support the utility of a biobank of FFPE material for the validation of innovative technologies and refinement of an algorithm for patients’ stratification.